Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

THC Clinical Trial

— THC-MEG  

Official title:

Multimodal Magnetoencephalography and Electroencephalography Exploration of the Acute Effects of THC Exposure on Neural Noise and Information Transmission Within Working Memory Networks

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05641766
• Other study ID #: 2000033383
• Secondary ID: 1R03DA054453-01A
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2024
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: Jose Cortes-Briones, PhD
• Phone: 203-903-5711
• Email: jose.briones[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to use non-invasive brain imaging methods (MEG and EEG) to characterize the effects of THC on brain activity during learning.

Description:

The goal of this study is to use multimodal MEG/EEG to gain novel insight into the acute effects of THC on neural noise and its interaction with the fast information processing dynamics of the brain's cognition-related functional neural networks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Cannabis use at least once in the past 12 months
• No cannabis use during the course of the study confirmed with negative urine toxicology at screening and on each test day
• Good physical and mental health

Exclusion Criteria:

• Cannabis naïve individuals
• Lifetime or current medical, psychiatric or psychosocial disorders or history that is deemed unsuitable for participation in the study per PI discretion.
• Positive pregnancy test, lactation, or refusal to practice birth control for the duration of the study and for two weeks following completion
• Major current or recent stressors
• Positive urine drug test
• Contraindication for Magnetic Resonance Imaging
• Treatment with psychotropic medication as per discretion of the PI
• IQ less than 80
• Weight exceeding 166kg
• Diagnosis of major psychotic or manic disorder in first-degree relatives.

Related Conditions & MeSH terms

• THC

Intervention

Drug:
• THC
Participants will receive THC into a rapidly flowing IV infusion.

Other:
• Placebo
Participants will receive an equivalent amount (about 1-2 ml) of placebo (sterile 190 proof USP ethanol). The placebo does not produce any measurable blood alcohol levels or subjective/behavioral effects.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System, Yale School of Medicine	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in brain dynamics during the Sternberg Working Memory Task	Changes in brain dynamics will be characterized during the Sternberg Working Memory Task where participants are presented with a list of items to memorize, followed by a memory maintenance period during which the subject must maintain the list of items in memory.	Baseline and starting at +15 minutes after start of IV THC or placebo administration
Secondary	Visual Analog Scale (VAS)	To confirm the acute effects of THC, feeling states associated with cannabis intoxication will be measured using a self-reported visual analogue scale of four feeling states ("high","anxious","calm and relaxed", and "tired") associated with cannabis effects. Subjects will be asked to score the perceived intensity of these feeling states at that moment on a 11mm line from 0=not at all to 100=extremely.	Baseline and starting at +15 minutes after start of IV THC or placebo administration
Secondary	Clinician Administered Dissociative Symptoms Scale (CADSS)	To confirm the acute effects of cannabis, perceptual alterations will be measured using the CADSS. This is a scale consisting of 19 self-report items and 8 clinician-rated items scored 0=not at all to 4=extremely. The scale captures alterations in environmental/time/body perception, feelings of unreality, and memory impairment.	Baseline and starting at +15 minutes after start of IV THC or placebo administration